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Curative Biotechnology Announces Completion of IND Enabling Reformulated Metformin HCL Eye Drop Study

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Curative Biotechnology Inc. (CUBT) announced on January 5, 2023, the successful completion of its IND enabling Tolerance and Toxicology Study of Metformin HCL Solution for eye drop use in rabbits. This milestone allows the company to prepare its IND application for a clinical trial targeting Intermediate Dry Age-Related Macular Degeneration (AMD) and Geographic Atrophy (GA). The studies address unmet medical needs, as no FDA-approved treatments currently exist for these conditions. The first human study will be conducted under a CRADA with the National Eye Institute.

Positive
  • Successful completion of IND enabling studies for Metformin HCL eye drops.
  • Preparation for the IND application marks progression towards clinical trials.
  • Targeting unmet medical needs in Dry AMD and GA, both lacking FDA-approved treatments.
Negative
  • CUBT has not yet generated any revenues.
  • Forward-looking statements indicate potential risks affecting business outcomes.

Boca Raton, FL, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Curative Biotechnology Inc. (OTC: CUBT) (“Curative Biotech” or the “Company”), a development-stage biomedical company focused on novel treatments for rare diseases and conditions, announced today that it has successfully completed its Investigational New Drug (IND) enabling Tolerance and Toxicology Study of Metformin HCL Solution by Topical Instillation (eye drops) in Rabbits.

Paul Michaels, Chairman and President of Curative Biotechnology, said, “We are pleased to announce the successful completion of these important studies, outlined in our Pre IND meeting with the FDA. We are now able to move on to preparing the Company’s first IND application to move our Metformin reformulation into a clinical trial to treat Intermediate Dry Age-Related Macular Degeneration (AMD) and Geographical Atrophy (GA) resulting from AMD.”

Michaels continued, “Both Dry AMD and GA are currently unmet medical needs with no FDA approved efficacious treatment options. As previously announced, we will be conducting the first in human study under a CRADA (Cooperative Research and Development Agreement) with the National Eye Institute of the National Institutes of Health, in Bethesda Maryland.”

About Macular Degeneration (AMD)

Macular Degeneration is a common eye disorder among people over 50 causing blurred or reduced central vision due from the deterioration of the inner layers of the macula. The macula is the part of the retina that gives the eye clear vision in the direct line of sight. Dry AMD accounts for 80-90% of all age-related macular degeneration (AMD cases), while wet AMD represents 10-20% of patient cases. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late-stage dry AMD).

About Curative Biotechnology, Inc. http://curativebiotech.com

Curative Biotechnology, Inc. (Curative Biotech) is a development stage biomedical company focused on novel therapies for rare diseases. The Company is focused on identifying, acquiring and developing disease modifying therapeutic drug candidates with a concentration on rare disease indications. Curative Biotech has ongoing programs in three different therapeutic areas: infectious disease, neuro oncology and degenerative eye disease. The Company’s pipeline includes IMT504, CURB906 and Metformin Reformulation. IMT504 is a novel immune therapy to treat rabies and an adjuvant for vaccines. CURB906 is a fully humanized CD56 monoclonal antibody carrying a cytotoxic drug conjugate directly to the tumor cancer site to kill the tumor by inhibiting tumor growth and migration of the tumor. Metformin Reformulation is targeting the treatment of intermediate and late-stage Age-Related Macular Degeneration (AMD) disease.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. CUBT is not yet generating revenues. Although forward-looking statements in this release reflect the good faith judgment of management, forward-looking statements are inherently subjected to known, unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements, including but not limited our ability to generate sufficient market acceptance for our products and services, our ability to generate sufficient operating cash flow, and general economic conditions. Readers are urged to carefully review and consider the various disclosures made by us in our reports filed with OTC Markets from time to time which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. We assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

Contact:

Steve Chizzik
Investor Relations
Curative Biotech (CUBT)
201-454-5845
ir@curativebiotech.com


FAQ

What is the latest news about Curative Biotechnology Inc. (CUBT)?

Curative Biotechnology has completed IND enabling studies for Metformin HCL eye drops, allowing them to prepare for a clinical trial.

What conditions is CUBT targeting with its Metformin reformulation?

CUBT is targeting Intermediate Dry Age-Related Macular Degeneration (AMD) and Geographic Atrophy (GA) with its Metformin reformulation.

When did Curative Biotechnology announce its progress in the IND study?

Curative Biotechnology announced its progress on January 5, 2023.

What is the significance of the IND application for CUBT?

The IND application is a crucial step for CUBT to begin clinical trials for its new treatment targeting AMD.

Are there any approved treatments for Dry AMD and GA?

Currently, there are no FDA-approved efficacious treatments for Dry AMD or Geographic Atrophy.

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